The Inclusion/Exclusion Criteria (IE) domain is a findings domain that contains those criteria that cause the subject to be in violation of the protocol inclusion/exclusion criteria. The trial design domain TI, is used to describe the criteria. One record for each of the inclusion and exclusion criteria for the trial are included in TI . This TI domain is not subject oriented. The TI domain is described in the section on Trial Design Description
Example
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Overview
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